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Does Rehabilitation After Total Knee Arthroplasty Work? - Feasibility Trial

A legfontosabb adatok

Ki végzi
Copenhagen University Hospital, Hvidovre
Hol
Dánia2 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Befejeződött
Résztvevők
25 fő vett részt
Kezdés
2023. aug. 22.
Befejezés
2024. szept. 10.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Usual care - Municipal exercise-based rehabilitation
  • Return to Everyday life
  • Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity
A regiszteradat frissítve
2025. július 9.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 6 feltétel megnézéseKevesebb

Ki vehet részt

  • Over 18 years of age
  • Residing in one of fourteen collaboration municipalities
  • Referral to primary total knee arthroplasty for osteoarthritis

Ki nem vehet részt

  • Severe surgical sequelae (i.e. requiring revision surgery, joint mobilization under anaestesia, or joint infection)
  • Insufficient danish skills (read/write/speak) to understand questionnaires and outcomes
  • Inability to provide informed consent

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

The aim of this feasibility trial is to investigate the feasibility of a trial intervention for a population of patients after total knee replacement for osteoarthritis. This study follows a hybrid type 1 design where the primary focus is on the feasibility of the intervention, and the secondary focus is on gaining a better understanding of context and acceptability.

A teljes eredeti leírásKevesebb

The main questions it aims to answer are:

* Recruitment (Process/Resources): Are patients willing to engage, and stay, in the trial (estimated by inclusion-rate, participant retention, etc.) and what reasons do patients give for not wishing to enroll or later dropping out of the trial? (inquired face-to-face, during enrolment). * Harms (Scientific): Does the non-exercise intervention appear "safe" (i.e. not harmful) for the patients? (estimated by for instance: adverse events, reasons for dropouts and sense of security). * Trial procedure feasibility (Management/Scientific): How well does recruitment and trial procedures work at trial sites? (estimated through feedback from site personnel). * Participant (patient) experienced acceptability of their assigned intervention: An interview-based follow-up using the Theoretical Framework of Acceptability.

Participants will be randomized to one of two interventions, at discharge from the hospital, following knee replacement, which are being tested for feasibility:

1. "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise). 2. "Return to everyday life" - no referral to municipal physiotherapy.

Participants in both groups are encouraged to follow WHO guidelines of physical activity, to the degree that their post-surgical symptoms allow (within their orthopedic surgeon's recommendations/limitations). All participants are given a "symptom guide", meaning a folder containing information on what to expect, and when and what to react to, during their recovery after the knee-replacement.

For clarity it should be mentioned, that the quantitative and qualitative data-outputs will be reported separately for improved clarity (the study is not a mixed methods design).

A vizsgálat 2 csoportja

  • Usual CareMár használt kezelés, összehasonlításként

    Referral to municipal rehabilitation after TKA

    Kezelés: Usual care - Municipal exercise-based rehabilitation és Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity

  • Return to Everyday LifeEgyéb csoport

    No referral to municipal rehabilitation after TKA

    Kezelés: Return to Everyday life és Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Feasibility of a Randomized Trial Comparing Exercise-based Rehabilitation With Non-exercise-based Recovery After Total Knee Arthroplasty; DRAW-TKA Hybrid 1 Feasibility Trial
Publikációk
A regiszteradat frissítve
2025. július 9.